Mirvetuximab Soravtansine for FRɑ-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

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On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted mirvetuximab soravtansine-gynx accelerated approval for patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatments.1 The FDA simultaneously approved the Ventana FOLR1 (FOLR-2.1) RxDx Assay as a companion diagnostic to select patients for this indication.

Supporting Efficacy Data

Approval was supported by findings in Study 0417 ( identifier NCT04296890), in which 104 evaluable patients with measurable disease, who were required to have received bevacizumab, received mirvetuximab soravtansine at 6 mg/kg (based on adjusted ideal body weight) intravenously (IV) every 3 weeks until disease progression or unacceptable toxicity. Patients with corneal disorders, ocular conditions requiring ongoing treatment, grade > 1 peripheral neuropathy, or noninfectious interstitial lung disease were excluded.

An investigator-assessed objective response was observed in 33 patients (31.7%, 95% confidence interval [CI] = 22.9%–41.6%), with a complete response in 5 (4.8%). Median response duration was 6.9 months (95% CI = 5.6–9.7 months).


Mirvetuximab soravtansine has a boxed warning for ocular toxicity. The agent also has warnings/precautions for pneumonitis, peripheral neuropathy, and embryofetal toxicity.

How It Is Used

The recommended mirvetuximab soravtansine dose is 6 mg/kg adjusted ideal body weight administered once every 3 weeks via IV infusion until disease progression or unacceptable toxicity. Use requires the presence of FRα tumor expression using an FDA-approved test.

Product labeling provides instructions on premedication to ameliorate infusion-related reactions and nausea/vomiting; pretreatment eye care; and dosage modification, including dose reduction, for adverse reactions such as keratitis/keratopathy, uveitis, pneumonitis, peripheral neuropathy, and infusion-related reactions/hypersensitivity. Use of mirvetuximab soravtansine in patients with moderate or severe hepatic impairment should be avoided.

Safety Profile

Among 106 patients receiving mirvetuximab soravtansine in Study 0417, the most common (≥ 20%) adverse events of any grade were vision impairment (50%), fatigue (49%), nausea (40%), keratopathy (37%), abdominal pain (36%), peripheral neuropathy (33%), diarrhea (31%), constipation (30%), and dry eye (27%); cataract occurred in 18%. The most common grade 3 or 4 adverse events included keratopathy (9%), vision impairment (7%), and abdominal pain (7%). The most common grade 3 or 4 laboratory abnormalities were decreased lymphocytes (7%) and decreased potassium (4%). Laboratory abnormalities of any grade occurring in at least 35% of patients were increased aspartate aminotransferase (50%), increased alanine aminotransferase (39%), and decreased lymphocytes (35%).

Serious adverse events occurred in 31% of patients, most commonly intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Adverse events led to discontinuation of treatment in 11% of patients, the most common of which were intestinal obstruction (2%) and thrombocytopenia (2%); one patient (0.9%) discontinued treatment due to visual impairment. Fatal adverse events occurred in 2% of patients; causes included small intestinal obstruction (1%) and pneumonitis (1%).

Mirvetuximab soravtansine has a boxed warning for ocular toxicity. The agent also has warnings/precautions for pneumonitis, peripheral neuropathy, and embryofetal toxicity. Patients should be advised not to breastfeed while receiving mirvetuximab soravtansine. 


1. Elahere (mirvetuximab soravtansine-gynx) injection, for intravenous use, prescribing information, ImmunoGen, Inc, November 2022. Available at Accessed November 18, 2022.